Context
The System for Monitoring and Preventing Shortages of Medicines in Croatia has been introduced in response to growing vulnerabilities in the medicine supply chain in Croatia, and across the EU more broadly, driven by a strong reliance on active pharmaceutical ingredients from Asia, constraints in manufacturing, sudden increases in demand for certain medicines such as during the pandemic COVID-19, and limited profitability of generic products.
Medicine shortages have severe negative effects on population health, including treatment delays, deterioration of patient conditions, medication errors due to the use of less effective or inappropriate alternatives, and increased mortality rates. They also strain health system finances by requiring investment in more expensive medicines and leading to longer, more complex, and costlier hospital stays. Given their impact on patient health, safety, and system finances, medicine shortages are a national priority. Failure to address them threatens the long-term sustainability of the health system.
Previous initiatives in medicine shortages monitoring and prevention in Croatia included the regular announcement of shortage periods by marketing authorisation holders to the Agency for Medicinal Products and Medical Devices which offers important insights but does not provide comprehensive information to fully tackle medicine shortage challenges.
Objectives
The project builds on several related initiatives at EU level, underpinned by the Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices, which specifically addresses problems in supply of medicines and preparedness of EU Member States to effectively response to the demand for medicines to safeguard their population health.
The European Medicine Agency (EMA) has published the Union list of critical medicines, containing human medicines for which continued supply is an EU priority. Regulation (EU) 2022/123 calls on Member States to reinforce and formalise the monitoring of critical medicinal products. At the EU level, the EMA has developed the European Shortages Monitoring Platform to gather information about medicine availability, supply, and demand to prevent, detect, and manage human medicine shortages in the European Union and the European Economic Area.
The project is focused on designing the system to monitor medicine distribution at the national level taking into account national organisation and specificity to obtain current data relevant for medicine shortages monitoring and prevention, while preserving the market business assumptions with an emphasis on business data privacy.
Implementation
The System for Monitoring and Preventing Shortages of Medicines in Croatia extends the set of information collected from the Croatian medicine distribution chain, considering disruptions in both inflow and outflow of medicines, and includes data on medicine stock, trade, supply plans, and shortages in pharmacies. Pharmacies in Croatia have so far reported their inability to dispense medicines to patients to the Agency for Medicinal Products and Medical Devices but the process has not been mandatory and has remained insufficiently organised and automated. Following the premise that tangible effects of shortages arise in pharmacies when a patient requests medicine but it cannot be dispensed, the system automates the process of reporting on shortages from all pharmacies located in Croatia, including those for the public and hospitals.
By implementing the system, Croatia introduces the legal obligation for reporting data related to medicine distribution based on the Law on Amendments to the Medicine Law (Official Gazette No. 136/2025), and in particular on the Regulation on the Type, Method, and Dynamics of Medicine Data Delivery (Official Gazette No. 150/2025), adopted in December 2025. The system is designed to provide a centralised access for both data collection and view of data processing results by authorised users.